(63 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888JF
This document is a 510(k) premarket notification approval letter for the HL888JF Non-invasive Blood Pressure Measurement System. It is an approval letter and does not contain detailed information about acceptance criteria or the specific study details that would prove a device meets acceptance criteria.
The letter acknowledges that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device meets the regulatory requirements for safety and effectiveness similar to already approved devices, but the letter does not present the specific acceptance criteria or the detailed study results used for that determination.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory approval and classification of the device rather than the technical details of its performance testing.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
HEALTH & LIFE CO., LTD. c/o Ms. Susan Chen 6F, No. 407, Chung Shan Road, Sec. 2 Chung Ho City, Taipei Hsien, China-Taiwan R.O.C.
Re: K030541 Trade Name: HL888JF Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: April 14, 2003 Received: April 15, 2003
Dear Ms. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Ms. Susan Chen
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
am D. Zuckerman. M.D.
Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) :
Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888JF
Indications For Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription USE ( | Over-The-Counter Use( √ ) | ||
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2) |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K030541 |
|---|---|
| --------------- | --------- |
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).